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Terminalia chebula Fruit Powder

Terminalia chebula Fruit Powder

Proposed For Comment Version 0.2

Terminalia chebula Fruit Powder

DEFINITION

The article consists of the dried fruit of Terminalia chebula Retz. (Family Combretaceae) reduced to a powder or very fine powder. It contains NLT 15% of hydrolyzable tannins calculated as the sum of chebulagic acid and chebulinic acid, on the dried basis.

Apply the Samples as bands to a suitable HPTLC plate and dry in air. Develop the chromatograms in a saturated chamber, remove the plate from the chamber, and dry. Examine under UV 254 nm before derivatization. Heat the plate at 100° for 3 min, then treat with Derivatization reagent. Examine under UV 366 nm.

System suitability: Under UV 254 nm prior to derivatization, the chromatogram of Standard solution B exhibits two intense bands in the lower half similar in RF and color to the chebulagic acid and chebulinic bands in the chromatogram of Standard solution A, with chebulagic acid having a lower RF. About four or five additional bands appear with increasing RF: two bands below chebulagic acid, a band above chebulinic acid, and one intense band at an RF of approximately 0.7. Under UV 366 nm after derivatization, about four intense blue fluorescence bands appear in the lower half and two blue fluorescence bands appear between RF of 0.6 and 0.7.

Acceptance criteria: Under UV 254 nm prior to derivatization, the chromatogram of Sample solution exhibits two intense bands in the lower half corresponding in RF and color to the chebulagic acid and chebulinic bands in the chromatogram of Standard solution A, with chebulagic acid having a lower RF. Two additional bands appear, one near the origin and another near an RF of approximately 0.7. Under UV 366 nm after derivatization, about four pale blue fluorescence bands appear in the lower half, and one blue fluorescence band appears with an RF of approximately 0.7.

• C. HPLC

Analysis: Proceed as directed in the Assay for Content of Constituents of Hydrolyzable Tannins.

Acceptance criteria: The chromatogram of the Sample solution exhibits peaks at the retention times corresponding to the peaks due to chebulagic acid and chebulinic acid in Standard solution B.

Using the chromatograms of Standard solution A, Standard solution B, and the reference chromatogram provided with the lot of USP Terminalia chebula Fruit Dry Extract RS being used, identify the retention times of the peaks corresponding to chebulagic acid and chebulinic acid. The approximate relative retention times of the peaks for chebulagic acid and chebulinic acid are 1.0 and 1.15, respectively.

Separately calculate the percentages of chebulagic acid and chebulinic acid in the portion of Terminalia chebula Fruit Powder taken:

Result = (rU/rS) × CS × (V/W) × F × 100

rU = peak area of the relevant analyte from the Sample solution

rS = peak area of the relevant analyte from Standard solution A

CS = concentration of the relevant analyte in Standard solution A (mg/mL)

• Microbial Enumeration Tests <61>: The total aerobic bacterial count does not exceed 105 cfu/g, the total combined molds and yeasts count does not exceed 103 cfu/g, and the bile-tolerant Gram-negative bacteria does not exceed 103 cfu/g.

• Tests for Specified Microorganisms <62>: Meets the requirements of the tests for the absence of Salmonella species and Escherichia coli

SPECIFIC TESTS

• Identification of Arjungenin

Standard solution: 0.2 mg/mL of USP Arjungenin RS in methanol

Sample solution: Sonicate about 10 g of Terminalia chebula Fruit Powder in 10 mL of dichloromethane for 10 min, centrifuge, and use the supernatant.

Apply the Samples as bands to a suitable HPTLC plate and dry in air. Develop the chromatograms in a saturated chamber, remove the plate from the chamber, and dry. Treat with Derivatization reagent. Examine under visible light.

Acceptance criteria: Under visible light, the Sample solution exhibits the most intense band in the middle, as a dark blue band corresponding in color and RFto the band due to arjungenin in the Standard solution.